Epidemiology and Benefit Risk, Sanofi U.S., 55 Corporate Drive, Bridgewater, NJ 08807, USA.
Global Pharmacovigilance, Sanofi U.S., 55 Corporate Drive, Bridgewater, NJ 08807, USA.
Diabetes Res Clin Pract. 2020 Nov;169:108452. doi: 10.1016/j.diabres.2020.108452. Epub 2020 Sep 17.
To estimate age- and sex-specific incidence rates (IRs) of non-traumatic lower limb amputations (LLA) in patients with type 2 diabetes mellitus (T2DM) using a claims database from the United States (US).
Patients with T2DM 18 years and older were identified using the Truven Health MarketScan database from January 1, 2007 to September 30, 2018. The overall and age- and sex-specific IRs of all non-traumatic LLA, minor LLA (amputation at or below the ankle), and major LLA (amputation above ankle) were calculated.
Among the 6,117,981 patients with T2DM, 14,627 LLA events occurred (minor LLA; 72.8%; major LLA: 27.2%). The IRs (95% CI) of all LLA, minor LLA, and major LLA per 1000 person-years or PY were 0.86 (0.85, 0.88), 0.63 (0.62, 0.64), and 0.23 (0.23, 0.24), respectively. The IR (95% CI) of all LLA per 1000 PY in males was higher compared to females [1.24 (1.22, 1.26) vs. 0.46 (0.45, 0.48)]. The incidence of all LLA increased with an increasing age (highest IR in age-group of ≥80 years).
This study identified males and older patients with T2DM at higher risk of developing LLA in the US, warranting further exploration of risk factors of LLA in these subgroups.
利用美国的索赔数据库估算 2 型糖尿病(T2DM)患者非创伤性下肢截肢(LLA)的年龄和性别特异性发病率(IR)。
使用 Truven Health MarketScan 数据库,从 2007 年 1 月 1 日至 2018 年 9 月 30 日,确定 18 岁及以上的 T2DM 患者。计算所有非创伤性 LLA、小截肢(踝部以下截肢)和大截肢(踝部以上截肢)的总体和年龄及性别特异性 IR。
在 6117981 例 T2DM 患者中,发生了 14627 例 LLA 事件(小截肢:72.8%;大截肢:27.2%)。每 1000 人年或 PY 的所有 LLA、小截肢和大截肢的 IR(95%CI)分别为 0.86(0.85,0.88)、0.63(0.62,0.64)和 0.23(0.23,0.24)。男性每 1000 PY 的所有 LLA 的 IR(95%CI)高于女性[1.24(1.22,1.26)与 0.46(0.45,0.48)]。所有 LLA 的发病率随年龄增长而增加(≥80 岁年龄组的发病率最高)。
本研究在美国确定了男性和年龄较大的 T2DM 患者发生 LLA 的风险较高,需要进一步探讨这些亚组中 LLA 的危险因素。